Trilaciclib frente a placebo en pacientes con cáncer de pulmón microcítico en estadio extenso (ES-SCLC) que reciben topotecán
Un estudio aleatorizado, doble ciego, controlado con placebo de trilaciclib frente a placebo en pacientes con cáncer de pulmón microcítico en estadio extenso (ES-SCLC) que reciben quimioterapia con topotecán
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Seville, España
- Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
- Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
- Measurable or evaluable disease as defined by RECIST v1.1
Exclusion Criteria:
- History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
- Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
- Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
- Radiotherapy within 2 weeks
- History of ILD/pneumonitis
- History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²) |
Participants will receive intravenous trilaciclib infusion
Otros nombres:
Participants will receive intravenous topotecan infusion
Otros nombres:
|
|
Comparador de placebos: Placebo + Topotecan 1.5 mg/m²
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²). |
Participants will receive intravenous topotecan infusion
Otros nombres:
Participants will receive intravenous placebo infusion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall survival (OS)
Periodo de tiempo: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
|
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan |
From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anti-tumor efficacy
Periodo de tiempo: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
|
To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan |
From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
|
|
Anti-tumor efficacy
Periodo de tiempo: From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
|
To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan |
From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
|
|
Anti-tumor efficacy
Periodo de tiempo: From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
|
To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan |
From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
|
|
Neutrophil-related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of cycle 1 (each cycle is 21 days)
|
Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1 |
From date of randomization until end of cycle 1 (each cycle is 21 days)
|
|
Neutrophil-related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Neutrophil-related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of G-CSF administration |
From date of randomization until end of treatment, assessed up to 52 months
|
|
RBC related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration |
From date of randomization until end of treatment, assessed up to 52 months
|
|
RBC related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of Week 5
|
RBC transfusions on or after Week 5 (occurrence) |
From date of randomization until end of Week 5
|
|
RBC related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of Week 5
|
RBC transfusions on or after Week 5 (number of transfusions) |
From date of randomization until end of Week 5
|
|
Platelet related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence) |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Platelet related myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions) |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Myeloprotection efficacy
Periodo de tiempo: From date of randomization until end of treatment, assessed up to 52 months
|
Number of hospitalizations due to chemotherapy-induced myelosuppression |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Chemotherapy dosing
Periodo de tiempo: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan. |
From the date of randomization until end of treatment, assessed up to 52 months
|
|
Chemotherapy dosing
Periodo de tiempo: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan. |
From the date of randomization until end of treatment, assessed up to 52 months
|
|
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
Periodo de tiempo: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest |
From the date of randomization until end of treatment, assessed up to 52 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Pharmacosmos Clinical and non-clinical Department, Pharmacosmos A/S
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células pequeñas
- Compuestos heterocíclicos
- Campeptecina
- Alcaloides
- Topotecán
- trilacíclib
Otros números de identificación del estudio
- G1T28-211
- 2022-502357-34-00 (Otro identificador: EU-CTR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .